DeliriumDELIRIUMNCT06326424
Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department
An observational study of Delirium and Dementia, run by Ohio State University at 1 site in United States.
Trial summary
Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Dementia, Hospital Acquired Condition
- What is being tested?
- Empatica EmbracePlus
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: older adults with dementia in the Emergency Department
Who may be able to join
- adults patients 65+ years old with a known diagnosis of dementia or medical team highly suspects or confirms dementia this visit.
- Emergency Department visit and/or hospitalization anticipated to last >4 more hours from the time of enrollment.
Who cannot join
- Intubation/mechanical ventilation
- Patients undergoing a procedure requiring sedation
- Patients who cannot consent due to cognitive impairment and do not have a legally authorized representative or caregiver present.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Hill, RN contact
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department Using Wrist Accelerometer Biosensors and Machine Learning
Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.
Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.
The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools.
Read the detailed description
Aim 1: (Patient and Caregiver Acceptability) Collect biosensor data on 60 older adults with dementia in the ED. The study population is any older adult with dementia in the ED who is anticipated to be in the ED or hospital for >4 hours. The investigators will place a wrist biosensor on the dominant hand (unless prohibited by IV placement, in which case the nondominant hand will be used). The investigators will ask questions about acceptability to caregiver (if available) and patient within 4-24 hour mark after biosensor placement. The acceptability questions are derived from the Theoretical Framework of Acceptability Questionnaire.
Study end data will be collected in person prior to discharge, but if unable to be completed before discharge from the hospital, the investigators will call them back at home to complete the final survey about acceptability.
Aim 2: Correlation of biosensor data with delirium phenotype. RA will perform a CAM ICU 7 upon enrollment, and at 24 and 48 hours (or upon discharge, whichever comes first). The investigators will also collect nurse scores for RASS (agitation scores documented as part of usual clinical care), times of scoring and any other delirium or cognitive assessments done as part of usual care (e.g., CAM -ICU, delirium triage screen, mini-cog).
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis.
Other data for covariates: medication history/medication administration records, age, gender, length of stay in the ED and in the hospital if applicable. Stage of dementia or most recent cognitive assessment. Baseline skin tone using the expanded Fitzpatrick scale (skin tone scale).
Participant exclusion criteria: patients who are intubated, getting electrical cardioversion or sedation in the ED. Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded.
- Conditions
- Delirium, Dementia, Hospital Acquired Condition
- Being tested
- Empatica EmbracePlus
- Keywords
- emergency department, delirium, older adults, dementia
- Medical subject headings
- Delirium, Dementia, Iatrogenic Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empatica EmbracePlusDevice
wear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity.
| Study group | Role | What they receive |
|---|---|---|
| Observational DELIRIUM cohort | We will follow up to 60 adults 65+ years old with dementia or suspected dementia who are likely to be in the emergency department, observation unit, or hospital for 48 hours. We will follow them for up to 48 hours while they wear an FDA approved biosensor watch and perform delirium checks. Receives: Device: Empatica EmbracePlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who develop delirium
The proportion of participants who develop delirium will be determined by one or more positive CAM-ICU 7 (Confusion Assessment Method- Intensive Care Unit 7) assessments during the study participation timeframe. The CAM-ICU 7 is a categorical test with 0 being no delirium and higher numbers signifying different levels of delirium.
Measured: over the 48 hours of study participation
Secondary outcomes (3)
Intervention Acceptability
Patient and caregiver acceptability of wearing the biosensor in the hospital will be assessed with a quick 6 question survey based off the Theoretical Framework of Acceptability. Survey questions use likert scales. For example, a score of 1 corresponds to being completely unacceptable and 5 corresponds to being completely acceptable.
Measured: Assessment completed at 48 hours or earlier if discharged prior to 48 hours
Biosensor data usability
Sometimes wrist biosensors are not able to detect signal well or can be dislodged or removed, which leads to periods of time without usable data. The biosensor data collected from each participant will be assessed for data quality and usability by the statistical analysis team.
Measured: 48 hours
Correlation of biosensor array data with clinical delirium
We will investigate the correlation of the biosensor array data (e.g., heart rate variability, electrodermal activity, and accelerometry) with the development of clinical delirium in the participants. This statistical analysis will be completed asynchronously after all the participants have finished all data collection for the study.
Measured: up to 48 hours of biosensor and clinical data per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Apr 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Southerland, Ohio State University
- Investigators
- Edward Boyer, MD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326424
- Sponsor's protocol ID
- 2023H0085
- Acronym
- DELIRIUM
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department Using Wrist Accelerometer Biosensors and Machine Learning
- ClinicalTrials.gov ID
- NCT06326424
- Acronym / sponsor ID
- DELIRIUM / 2023H0085
- Conditions
- Delirium, Dementia, Hospital Acquired Condition
- Keywords
- emergency department, delirium, older adults, dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.
Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.
The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools.
Detailed description
Aim 1: (Patient and Caregiver Acceptability) Collect biosensor data on 60 older adults with dementia in the ED. The study population is any older adult with dementia in the ED who is anticipated to be in the ED or hospital for >4 hours. The investigators will place a wrist biosensor on the dominant hand (unless prohibited by IV placement, in which case the nondominant hand will be used). The investigators will ask questions about acceptability to caregiver (if available) and patient within 4-24 hour mark after biosensor placement. The acceptability questions are derived from the Theoretical Framework of Acceptability Questionnaire.
Study end data will be collected in person prior to discharge, but if unable to be completed before discharge from the hospital, the investigators will call them back at home to complete the final survey about acceptability.
Aim 2: Correlation of biosensor data with delirium phenotype. RA will perform a CAM ICU 7 upon enrollment, and at 24 and 48 hours (or upon discharge, whichever comes first). The investigators will also collect nurse scores for RASS (agitation scores documented as part of usual clinical care), times of scoring and any other delirium or cognitive assessments done as part of usual care (e.g., CAM -ICU, delirium triage screen, mini-cog).
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis.
Other data for covariates: medication history/medication administration records, age, gender, length of stay in the ED and in the hospital if applicable. Stage of dementia or most recent cognitive assessment. Baseline skin tone using the expanded Fitzpatrick scale (skin tone scale).
Participant exclusion criteria: patients who are intubated, getting electrical cardioversion or sedation in the ED. Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational DELIRIUM cohort | – | Device: Empatica EmbracePlusWe will follow up to 60 adults 65+ years old with dementia or suspected dementia who are likely to be in the emergency department, observation unit, or hospital for 48 hours. We will follow them for up to 48 hours while they wear an FDA approved biosensor watch and perform delirium checks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- older adults with dementia in the Emergency Department
Key inclusion criteria (2 listed)
- adults patients 65+ years old with a known diagnosis of dementia or medical team highly suspects or confirms dementia this visit.
- Emergency Department visit and/or hospitalization anticipated to last >4 more hours from the time of enrollment.
Key exclusion criteria (3 listed)
- Intubation/mechanical ventilation
- Patients undergoing a procedure requiring sedation
- Patients who cannot consent due to cognitive impairment and do not have a legally authorized representative or caregiver present.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empatica EmbracePluswear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity. | Device | Observational DELIRIUM cohort |
Primary outcome
Proportion of participants who develop delirium
Time frame: over the 48 hours of study participation
The proportion of participants who develop delirium will be determined by one or more positive CAM-ICU 7 (Confusion Assessment Method- Intensive Care Unit 7) assessments during the study participation timeframe. The CAM-ICU 7 is a categorical test with 0 being no delirium and higher numbers signifying different levels of delirium.
3 secondary outcomes
Intervention Acceptability
Time frame: Assessment completed at 48 hours or earlier if discharged prior to 48 hours
Biosensor data usability
Time frame: 48 hours
Correlation of biosensor array data with clinical delirium
Time frame: up to 48 hours of biosensor and clinical data per participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Hill, RN contact
Edward Boyer, MD study director
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Dementia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Southerland, MD MPH (614-366-8375, lauren.southerland@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who develop delirium (time frame: over the 48 hours of study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.